Dr. Bardia on the Rationale for the AMEERA-5 Trial in ER+/HER2- Breast Cancer

Aditya Bardia, MD, MPH, attending physician, director of Precision Medicine at the Center for Breast Cancer and founding director of the Molecular and Precision Medicine Metastatic Breast Cancer Clinic, Massachusetts General Hospital Cancer Center, and assistant professor of medicine, Harvard Medical School, discusses the rationale for the ongoing phase 3 AMEERA-5 trial (NCT04478266) in estrogen receptor (ER)–positive, HER2-negative breast cancer. 

ER-positive breast cancer is the most common subtype of breast cancer, says Bardia. Currently, endocrine therapy, such as the aromatase inhibitor letrozole (Femara), in combination with a CDK4/6 inhibitor, such as palbociclib (Ibrance), remains the standard frontline therapy for patients with metastatic ER-positive disease, Bardia explains. However, improved endocrine agents are needed to overcome endocrine resistance, Bardia says.

Amcenestrant is an optimized, oral, selective ER degrader that dually antagonizes and degrades the ER, says Bardia. As a result, the ER signaling pathway is inhibited, Bardia adds.

During the 2021 ASCO Annual Meeting, the study schema for the AMEERA-5 trial, which is evaluating amcenestrant plus palbociclib vs letrozole plus palbociclib in ER-positive/HER2-negative advanced breast cancer, was presented in a virtual poster. The trial is currently enrolling, as is the phase 1/2 AMEERA-1 trial (NCT03284957) evaluating amcenestrant alone or in combination with other anticancer therapies in ER-positive, HER2-negative breast cancer, concludes Bardia.